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Study was never approved by the IRB
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This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Active Comparator | Subjects will undergo general anesthesia with endotracheal intubation. |
|
| Conscious Sedation | Experimental | Subjects will undergo conscious sedation anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Anesthesia | Procedure | General anesthesia by standard endotracheal intubation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-on-table |
| <1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with serious adverse events |
| within 30 days |
| Length of stay |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure Complications |
| within 30 days |
| Quality of Life | Kansas City Cardiomyopathy Questionnaire at 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph DeRose, MD | Montefiore Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26892451 | Background | Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D016292 | Conscious Sedation |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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| Conscious Sedation | Procedure | Conscious sedation |
|
| within 30 days |
| Readmissions | Number of patients readmitted within 30 days of initial procedure | within 30 days |
| Number of Patients with Valve Complications |
| within 30 days |
| Contrast usage | Amount of contrast used in mL for procedure | <1 day |
| Fluoroscopy time | Amount of time fluoroscopy used | <1 day |
| Procedure start to 30 days |
| D014694 |
| Ventricular Outflow Obstruction |